Device Classification Name |
Sampler, Amniotic Fluid (Amniocentesis Tray)
|
510(k) Number |
K901643 |
Device Name |
ISOFLO(TM) AMNIOCENTESIS TRAY |
Applicant |
HEALTHDYNE CARDIOVASCULAR, INC. |
45 PARKER ST., SUITE A |
IRVINE,
CA
92618 -1658
|
|
Applicant Contact |
BILL WELCH |
Correspondent |
HEALTHDYNE CARDIOVASCULAR, INC. |
45 PARKER ST., SUITE A |
IRVINE,
CA
92618 -1658
|
|
Correspondent Contact |
BILL WELCH |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 04/09/1990 |
Decision Date | 07/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|